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3. Abstract 982:LKB1loss rewires stress signaling-induced apoptotic protein dynamics and sensitizesKRAS-mutant non-small cell lung cancers to combined MAPK + MCL-1 blockade

Author

Li, Chendi, primary, Shen, Yi, additional, Syed, Mohammed Usman, additional, Oh, Audris, additional, Fraser, Cameron, additional, Kreuzer, Johannes, additional, Webster, Kaitlyn, additional, Morris, Robert, additional, Caenepeel, Sean, additional, Saiki, Anne Y., additional, Rex, Karen, additional, Lipford, James, additional, Hass, Wilhelm, additional, Sarosiek, Kristopher, additional, Hughes, Paul E., additional, and Hata, Aaron N., additional

Published
2021
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5. Supplemental Material, sj-docx-6-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-6-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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6. Supplemental Material, sj-docx-7-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-7-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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7. Supplemental Material, sj-docx-3-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-3-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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8. Supplemental Material, sj-docx-1-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-1-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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9. Supplemental Material, sj-docx-4-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-4-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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10. Supplemental Material, sj-docx-5-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-5-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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11. Supplemental Material, sj-docx-8-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-8-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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12. Supplemental Material, sj-docx-9-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-9-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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13. Supplemental Material, sj-docx-2-ijt-10.1177_10915818211022965 - Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
FOS: Clinical medicine, 111599 Pharmacology and Pharmaceutical Sciences not elsewhere classified
Abstract

Supplemental Material, sj-docx-2-ijt-10.1177_10915818211022965 for Nonclinical Safety Profile of Sotorasib, a KRASG12C-Specific Covalent Inhibitor for the Treatment of KRAS p.G12C-Mutated Cancer by Katsu Ishida, Jonathan A. Werner, Rhian Davies, Fan Fan, Barbara Thomas, Jan Wahlstrom, James Russell Lipford and Thomas Monticello in International Journal of Toxicology

Published
2021
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14. Mutation in the mismatch repair gene Msh6 causes cancer susceptibility

Author

Edelmann, Winfred, Yang, Kan, Umar, Asad, Heyer, Joerg, Lau, Kirkland, Fan, Kunhua, Lidke, Wolfgang, Cohen, Paula E., Kane, Micthel F., Lipford, James R., Yu, Nianjun, Crouse, Gray F., Pollard, Jeffrey W., Kunkel, Thomas, Lipkin, Martin, Kolonder, Richard, and Kucherlapati, Raju

Subjects
Mice -- Genetic aspects, Cancer -- Genetic aspects, Gene mutations -- Research, Biological sciences
Abstract

A study was conducted on the cloned Msh6 gene using gene targeting. Results have shown that mice without Msh6 can exist, but homozygous mutant cells reveal one nucleotide mismatch repair effect. Moreover, these mice developed several tissue tumors that led to a significant reduction in their life span. These results indicated that Msh6 mutation causes cancer susceptibility and may be associated with hereditary cancer predisposition.

Published
1997

15. Nonclinical Safety Profile of Sotorasib, a KRAS G12C -Specific Covalent Inhibitor for the Treatment of KRAS p.G12C -Mutated Cancer.

Author

Ishida, Katsu, Werner, Jonathan A., Davies, Rhian, Fan, Fan, Thomas, Barbara, Wahlstrom, Jan, Lipford, James Russell, and Monticello, Thomas

Subjects
NEPHROTOXICOLOGY, PITUITARY gland, THYROID gland, FETAL development, HUMAN genes, TUMOR treatment, ION channels
Abstract

Sotorasib is a first-in-class KRASG12C covalent inhibitor in clinical development for the treatment of tumors with the KRAS p.G12C mutation. A comprehensive nonclinical safety assessment package, including secondary/safety pharmacology and toxicology studies, was conducted to support the marketing application for sotorasib. Sotorasib was negative in a battery of genotoxicity assays and negative in an in vitro phototoxicity assay. Based on in vitro assays, sotorasib had no off-target effects against various receptors, enzymes (including numerous kinases), ion channels, or transporters. Consistent with the tumor-specific target distribution (ie, KRASG12C), there were no primary pharmacology-related on-target effects identified. The kidney was identified as a target organ in the rat but not the dog. Renal toxicity in the rat was characterized by tubular degeneration and necrosis restricted to a specific region suggesting that the toxicity was attributed to the local formation of a putative toxic reactive metabolite. In the 3-month dog study, adaptive changes of hepatocellular hypertrophy due to drug metabolizing enzyme induction were observed in the liver that was associated with secondary effects in the pituitary and thyroid gland. Sotorasib was not teratogenic and had no direct effect on embryo-fetal development in the rat or rabbit. Human, dog, and rat circulating metabolites, M24, M10, and M18, raised no clinically relevant safety concerns based on the general toxicology studies, primary/secondary pharmacology screening, an in vitro human ether-à-go-go-related gene assay, or mutagenicity assessment. Overall, the results of the nonclinical safety program support a high benefit/risk ratio of sotorasib for the treatment of patients with KRAS p.G12C -mutated tumors. [ABSTRACT FROM AUTHOR]

Published
2021
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16. Mutation in the DNA mismatch repair gene homologue hMLH1 is associated with hereditary non-polyposis colon cancer

Author

Bronner, C. Eric, Baker, Sean M., Morrison, Paul T., Warren, Gwynedd, Smith, Leslie G., Lescoe, Mary Kay, Kane, Michael, Earabino, Christine, Lipford, James, Lindoblom, Annika, Tannergard, Pia, Bollag, Roni J., Godwin, Alan R., Ward, David C., Nordenskjold, Magnus, Fishel, Richard, Kolodner, Richard, and Liskay, R. Michael

Subjects
Colorectal cancer -- Genetic aspects, Bacterial genetics -- Research, Environmental issues, Science and technology, Zoology and wildlife conservation
Abstract

A human gene encodes a human MutL homologue protein (hMLH1) which is similar to the bacterial DNA mismatch protein MutL. The protein hMLH1 is situated on human chromosome 3p21-23. hMLH1, like the human DNA mismatch pair gene homologue hMSH2, can be related to non-polyposis colon cancer.

Published
1994

17. Abstract 2861: Validation of PERK as an oncology target: A role for the unfolded protein response in cancer

Author

Dellamaggiore, Ken, primary, Mitchell, Petia, additional, Sun, Ji-Rong, additional, Jones, Jeffrey, additional, Muchamuel, Tony, additional, Hollenback, David, additional, Tadesse, Seifu, additional, Booker, Shon, additional, Hong, Fang-Tsao, additional, Smith, Adrian, additional, Rose, Mark, additional, Beltran, Pedro, additional, and Lipford, James R., additional

Published
2016
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19. Structure of the Human MSH2 Locus and Analysis of Two Muir-Torre Kindreds for msh2 Mutations

Author

Kolodner, Richard D., primary, Hall, Nigel R., additional, Lipford, James, additional, Kane, Michael F., additional, Rao, M.R.S., additional, Morrison, Paul, additional, Wirth, Lori, additional, Finan, Paul J., additional, Burn, John, additional, Chapman, Pamela, additional, Earabino, Christene, additional, Merchant, Elizabeth, additional, and Bishop, D.Timothy, additional

Published
1994
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20. Mutation in the DNA mismatch repair gene homologue hMLH 1 is associated with hereditary non-polyposis colon cancer

Author

Bronner, C. Eric, primary, Baker, Sean M., additional, Morrison, Paul T., additional, Warren, Gwynedd, additional, Smith, Leslie G., additional, Lescoe, Mary Kay, additional, Kane, Michael, additional, Earabino, Christine, additional, Lipford, James, additional, Lindblom, Annika, additional, Tannergård, Pia, additional, Bollag, Roni J., additional, Godwin, Alan R., additional, Ward, David C., additional, Nordenskj⊘ld, Magnus, additional, Fishel, Richard, additional, Kolodner, Richard, additional, and Liskay, R. Michael, additional

Published
1994
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